Single-Dose Sputnik Light Approved For Phase 3 Bridging Trials In India
NDTV
Sputnik Light Vaccine: The single-dose COVID-19 vaccine Sputnik Light received approval from the Drugs Controller General of India (DCGI) today to conduct phase 3 bridging trials in India.
The single-dose COVID-19 vaccine Sputnik Light received approval from the Subject Expert Committee (SEC) of the Drugs Controller General of India (DCGI) today to conduct phase 3 bridging trials in India.
Last year, Hyderabad-based Dr Reddy's Laboratories had partnered with the Russian Direct Investment Fund (RDIF) to conduct phase 3 trials of the vaccine. After the company submitted safety, immunogenicity and efficacy data, the SEC granted permission for conducting the trials in India, a statement by the Central Drugs Standard Control Organisation said.
"The committee noted that the firm has now presented the safety and immunogenicity along with the longevity of the antibodies which gives a measure of persistence of antibodies in the participants," the statement added.
In May, Dr Reddy's CEO Deepak Sapra told NDTV that the company will have discussions with the government and the regulator in June for an immediate launch. But in July, the expert committee refused to grant emergency-use authorisation for Sputnik Light, ruling out third phase trials for the vaccine developed by Russia's Gamaleya Institute. The committee had said it did not find any "scientific rationale" for the trials to be conducted.
